There is no evidence that galantamine alters the course of the underlying dementing process.

IMPORTANT SAFETY INFORMATION

In clinical trials, once-daily treatment with RAZADYNE^® ER was well tolerated and the adverse events were similar to those seen with twice daily RAZADYNE^® tablets.

Anesthesia
Cholinesterase inhibitors, such as galantamine HBr, are likely to exaggerate the neuromuscular blocking effects of succinylcholine-type and similar neuromuscular blocking agents during anesthesia.

Cardiovascular events
Because of their pharmacologic action, cholinesterase inhibitors have vagotonic effects on the sinoatrial (SA) and atrioventrical (AV) nodes, leading to bradycardia and AV block. These actions may be particularly important to patients with superventricular cardiac conduction disorders, or to patients taking other drugs concomitantly that significantly slow heart rate. In clinical trials, galantamine HBr was associated with more frequent reports of bradycardia and syncope vs placebo. Post marketed surveillance of marketed anticholinesterase inhibitors has shown that bradycardia and all types of heart block have been reported in patients both with and without known underlying cardiac conduction abnormalities. All patients should be considered at risk for adverse effects on cardiac conduction.

Gastrointestinal
Cholinesterase inhibitors may increase gastric acid secretion. Patients should be monitored closely for symptoms of active or occult gastrointestinal bleeding, especially those with an increased risk of developing ulcers, eg, those with a history of ulcer disease or patients using concurrent nonsteroidal anti-inflammatory drugs.

Genitourinary
Cholinesterase inhibitors may cause bladder outflow obstruction.

Neurological conditions
Cholinesterase inhibitors are believed to have some potential to cause generalized convulsions. Seizure activity may also be a manifestation of Alzheimer's disease. In clinical trials, there was no increase in the incidence of convulsions with galantamine HBr compared with placebo.

Pulmonary conditions
Cholinesterase inhibitors should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease.

Deaths in subjects with mild cognitive impairment (MCI)
In controlled trials in elderly subjects with MCI, 13 subjects on RAZADYNE^® (n=1026) and 1 subject on placebo (n=1022) died of various causes. About half of the RAZADYNE^® deaths appeared to result from various vascular causes (myocardial infarction, stroke, and sudden death). RAZADYNE^® and RAZADYNE^® ER are not indicated for the treatment of MCI.

Hepatic or renal impairment
In patients with moderately impaired hepatic or renal function, dose titration should proceed cautiously. The use of RAZADYNE^® or RAZADYNE^® ER in patients with severe hepatic impairment or severely impaired renal function
(Cl _cr < 9 mL/min) is not recommended.

Most common Adverse Events
The most common adverse events occuring at rate of at least 5% and at least twice that of placebo at the recommended maintenance dose of either 16 or 24 mg/day under conditions of every 4 week dose escalation for each 8-mg increase were nausea, vomiting, diarrhea, anorexia, and weight decrease.

Please see full Prescribing Information.

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This page was last updated on May 14 2012 at 12:14:23 EDT.